FDA Opioid REMS Proposal Leaves Advisory Panel Wanting More - i.e. Mandatory Training
This article was originally published in The Pink Sheet Daily
Prior training programs have been much smaller in scope, OND Director John Jenkins points out.
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US FDA is once again asking whether its opioid Risk Evaluation & Mitigation Strategy program for opioids should make continuing education requirements mandatory for prescribers. This time there may be no choice but to move forward with the plan.
Opioids May All Require Mandatory Education As US FDA Expands REMS To Immediate-Release Formulations
Agency has been hesitant to take the steps because of logistical difficulties of creating an enormous program, but has been pushed by its risk management advisory committee, among others.
FDA advisory committee's preferred approaches – linking mandatory training to DEA registration or state medical board licensing – are outside agency's existing regulatory authority.